GUIDELINES FOR HUMAN EMBRYONIC STEM CELL RESEARCH
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
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NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.
This material is based on work supported by the National Academies, the Ellison Medical Foundation, and the Greenwall Foundation.
Library of Congress Cataloging-in-Publication Data
Guidelines for human embryonic stem cell research / Board on Life Sciences, National Research Council, Board on Health Sciences Policy, Institute of Medicine.
p. cm.
Includes bibliographical references and index.
ISBN 0-309-09653-7 (pbk.)—ISBN 0-309-55024-6 (pdf) 1. Embryonic stem cells—Research. 2. Human embryo—Research. I. National Research Council (U.S.). Board on Life Sciences. II. National Research Council (U.S.). Board on Health Sciences Policy.
QH588.S83G85 2005
616′.02774—dc22
2005016338
Additional copies of this report are available from the
National Academies Press,
500 Fifth Street, NW, Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu.
Cover: A cluster of motor neurons and neural fibers derived from human embryonic stem cells in the lab of University of Wisconsin-Madison stem cell researcher and neurodevelopmental biologist Su-Chun Zhang. The motor neurons are shown in red; neural fibers appear green and the blue specks indicate DNA in cell nuclei. These motor neurons were developed from one of James Thomson’s original human embryonic stem cell lines. Copyright for the photograph is held by the University of Wisconsin’s Board of Regents.
Copyright 2005 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America
THE NATIONAL ACADEMIES
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COMMITTEE ON GUIDELINES FOR HUMAN EMBRYONIC STEM CELL RESEARCH
RICHARD O. HYNES (Co-Chair),
Massachusetts Institute of Technology, Cambridge, Massachusetts
JONATHAN D. MORENO (Co-Chair),
University of Virginia, Charlottesville, Virginia
ELIZABETH PRICE FOLEY,
Florida International University, Miami, Florida
NORMAN FOST,
University of Wisconsin, Madison, Wisconsin
H. ROBERT HORVITZ,
Massachusetts Institute of Technology, Cambridge, Massachusetts
MARCIA IMBRESCIA,
Arthritis Foundation, Lynnfield, Massachusetts
TERRY MAGNUSON,
University of North Carolina, Chapel Hill, North Carolina
CHERYL MWARIA,
Hofstra University, Hempstead, New York
JANET ROSSANT,
Mount Sinai Hospital, Toronto, Ontario, Canada
JANET D. ROWLEY,
University of Chicago, Chicago, Illinois
Board on Life Sciences Liaison to the Committee
R. ALTA CHARO,
University of Wisconsin, Madison, Wisconsin
Staff
FRANCES SHARPLES, Study Director
ROBIN SCHOEN, Senior Program Officer
MATTHEW D. MCDONOUGH, Program Assistant
KATHI E. HANNA, Science Writer
NORMAN GROSSBLATT, Senior Editor
BOARD ON LIFE SCIENCES
COREY S. GOODMAN (Chair),
Renovis Inc., South San Francisco, California
ANN M. ARVIN,
Stanford University School of Medicine, Stanford, California
JEFFREY L. BENNETZEN,
University of Georgia, Athens, Georgia
RUTH BERKELMAN,
Emory University, Atlanta, Georgia
R. ALTA CHARO,
University of Wisconsin, Madison, Wisconsin
DENNIS CHOI,
Merck Research Laboratories, West Point, Pennsylvania
JEFFREY L. DANGL,
University of North Carolina, Chapel Hill, North Carolina
PAUL R. EHRLICH,
Stanford University, Palo Alto, California
JAMES M. GENTILE,
Research Corporation of America, Tucson, Arizona
ED HARLOW,
Harvard Medical School, Boston, Massachusetts
DAVID HILLIS,
University of Texas, Austin, Texas
KENNETH F. KELLER,
University of Minnesota, Minneapolis, Minnesota
RANDALL MURCH,
Virginia Polytechnic Institute and State University, Alexandria, Virginia
GREGORY A. PETSKO,
Brandeis University, Waltham, Massachusetts
STUART L. PIMM,
Duke University, Durham, North Carolina
BARBARA A. SCHAAL,
Washington University, St. Louis, Missouri
JAMES TIEDJE,
Michigan State University, East Lansing, Michigan
KEITH YAMAMOTO,
University of California, San Francisco, California
Staff
FRANCES E. SHARPLES, Director
KERRY A. BRENNER, Senior Program Officer
ROBIN SCHOEN, Senior Program Officer
MARILEE K. SHELTON-DAVENPORT, Senior Program Officer
ROBERT T. YUAN, Senior Program Officer
ADAM P. FAGEN, Program Officer
ANN REID, Program Officer
EVONNE P. Y. TANG, Program Officer
SETH STRONGIN, Senior Program Assistant
MATTHEW D. MCDONOUGH, Program Assistant
DENISE GROSSHANS, Financial Associate
BOARD ON HEALTH SCIENCES POLICY
PHILIP PIZZO (Chair),
Stanford University School of Medicine, Stanford, California
LESLIE BENET,
University of California, San Francisco, California
DAVID BLUMENTHAL,
Harvard Medical School & Massachusetts General Hospital, Boston, Massachusetts
GAIL H. CASSELL,
Eli Lilly and Company, Indianapolis, Indiana
ELLEN WRIGHT CLAYTON,
Vanderbilt University Law School, Nashville, Tennessee
DAVID COX,
Perlegen Sciences, Mountain View, California
NANCY DUBLER,
Montefiore Medical Center & The Albert Einstein College of Medicine, Bronx, New York
ROBERT GIBBONS,
University of Illinois at Chicago, Chicago, Illinois
LYNN R. GOLDMAN,
Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
BERNARD GOLDSTEIN,
University of Pittsburgh, Pittsburgh, Pennsylvania
MARTHA N. HILL,
Johns Hopkins University School of Nursing, Baltimore, Maryland
DANIEL MASYS,
Vanderbilt University Medical Center, Nashville, Tennessee
JONATHAN D. MORENO,
University of Virginia, Charlottesville, Virginia
E. ALBERT REECE,
University of Arkansas, Little Rock, Arkansas
MYRL WEINBERG,
National Health Council, Washington, DC
MICHAEL J. WELCH,
Washington University School of Medicine, St. Louis, Missouri
MARY WOOLLEY,
Research!America, Alexandria, Virginia
Staff
ANDREW M. POPE, Director
AMY HAAS, Administrative Assistant
Preface
We are pleased to offer our committee’s report on guidelines for human embryonic stem cell research. This report and its recommendations are the result of many hours of committee meetings as well as a public workshop. During those sessions we heard from many dedicated and talented people who represent a wide range of views. We have tried to take these diverse perspectives into account in a report that mirrors the seriousness with which we have reflected upon them. Our task was made more difficult and also more significant by events in the worlds of science and public affairs, which altered the terrain even as we explored it. All of us on the committee have appreciated the opportunity to be part of this important and timely effort.
Great possibilities for improvements in human health are offered by research using human stem cells, both adult and embryonic. Like many scientific advances, these technologies raise questions about balancing the evident promise against the potential for inappropriate application. In the case of embryonic stem cell research, there are differing opinions within our society about the relative merits and risks of various approaches and there are philosophical differences about what is or is not appropriate. Some believe strongly that we should not turn away from the promise that embryonic stem cells will provide new therapeutic advances. Others believe that the derivation and application of human embryonic stem cells will undermine the dignity of human life. These disparate views are deeply and sincerely held and must be considered as we move forward in advancing this research. Some of the qualms arise from unfamiliarity and the “shock of the new,” but others arise from concerns about the nature of human life, about ethical treatment of reproductive
materials and about exploitation of donors of such materials. Those ethical concerns need to be balanced against the duty to provide the best medical care possible, enhancing the quality of life and alleviating suffering for many people. The challenge to our society is to achieve that balance.
Scientific inquiry should not proceed unfettered, without consideration for the ethical and public policy imperatives of the society in which it operates. On the other hand, concerns about potential ethical complexities should be cause for judicious oversight and regulation, not necessarily for prohibition. Our democratic society should be capable of entertaining challenges to familiar beliefs and adapting to new conditions without yielding on its fundamental values. We believe that it is possible to do so, that human dignity will be enhanced, rather than diminished, by the great project of addressing the suffering that attends illness. Freedom of inquiry and a confident attitude toward the future are at the heart of America’s civic philosophy, in which the freedom to explore controversial ideas is celebrated rather than suppressed. That is one reason that our country’s scientific establishment is the envy of the world, a source of our inventive energy that was celebrated by Thomas Jefferson who wrote, “Liberty is the great parent of science and of virtue; and a nation will be great in both in proportion as it is free.”
In that spirit we offer this report.
Richard O. Hynes
Jonathan D. Moreno
Co-chairs, Committee on Guidelines for Human Embryonic Stem Cell Research
Acknowledgments
Like all National Academies reports, this one is the result of the contributions of many people. First, we sincerely thank all the speakers who participated in our workshop, “Guidelines for Human Embryonic Stem Cell Research,” on October 12-13, 2004. A workshop agenda and a list of the workshop speakers with their biographies are included in Appendix C. Without their input, this report would not have been possible.
Second, we would like to thank the Ellison Medical Foundation and the Greenwall Foundation for their financial support of this activity.
This report has been reviewed in draft form by persons chosen for their diverse perspectives and technical expertise in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards of objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following for their review of this report:
Alexander Capron, World Health Organization
Mark Fishman, Novartis
Linda Giudice, Stanford School of Medicine
Virginia Hinshaw, University of California, Davis
Brigid Hogan, Duke University
Bernard Lo, University of California, San Francisco
Michael Manganiello, Christopher Reeve Foundation
Doug Melton, Harvard University
Catherine Racowsky, Brigham and Women’s Hospital
Laura Robbins, Weill Cornell Medical College
John Robertson, University of Texas Law School
Harold Shapiro, Princeton University
Harold Varmus, Memorial Sloan-Kettering Cancer Center
LeRoy Walters, Georgetown University
Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Floyd E. Bloom, Scripps Research Institute, and William H. Danforth, Washington University. Appointed by the National Research Council, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.
Finally, we wish to acknowledge Dr. Kathi Hanna, our superb science writer, and the National Research Council staff (Fran Sharples, Robin Schoen, Matt McDonough, and Norman Grossblatt) for their thorough, thoughtful, and efficient assistance with all aspects of the preparation of this report.